Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body.
Reason for recall: Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator straight through the center of the valve and fully advancing it into the sheath body. Distribution: Global Distribution. US Nationwide. Quantity: 508,151 units Lot/code info: UDI-DI: 00191506043131; Lots: CL12695, CL12696, CL12699, CL12700, CL12703, CL12808, CL12816, CL12817, CL12823, CL12834, CL12835, CL12836, CL12853, CL12860, CL12882, CL12883, CL12884, CL12891, CL12907, CL12908, CL12909, CL12919, CL12949, CL12950, CL12969, CL12976, CL12979, CL12980, CL13005, CL13010, CL13011, CL13012, CL13018, CL13032, CL13033, CL13034, CL13037, CL13056, CL13057, CL13058, CL13074, CL13075, CL13076, CL13077, CL13097, CL13098, CL13099, CL13100, CL13104, CL13115, CL13116, CL13117, CL13118, CL13119, CL13135, CL13136, CL13137, CL13138, CL13139, CL13156, CL13157, CL13191, CL13192, CL13193, CL13194, CL13197, CL13208, CL13209, CL13210, CL13215, CL13216, CL13217, CL13224, CL13229, CL13230, CL13257, CL13258, CL13288, CL13289, CL13337, CL13338, CL13365, CL13366, CL13384, CL13398, CL13399, CL13419, CL13420, CL13423, CL13467, CL13469, CL13470, CL13471, CL13472, CL13517, CL13525, CL13526, CL13527, CL13528, CL13535, CL13536, CL13541, CL13550, CL13551, CL13552, CL13553, CL13555, CL13564, CL13565, CL13566, CL13571, CL13574, CL13575, CL13576, CL13598, CL13599, CL13616, CL13637, CL13642, CL13643, CL13644, CL13665, CL13666, CL13667, CL13668, CL13704, CL13705, CL13706, CL13715, CL13716, CL13721, CL13734, CL13735, CL13736, CL13761, CL13762, CL13763, CL13798, CL13799, CL13800, CL13822, CL13825, CL13826, CL13835, CL13836, CL13837, CL13858, CL13859, CL13860, CL13912, CL13913, CL13914, CL13927, CL13928, CL13929, CL13942, CL13944, CL13945, CL13974, CL13975, CL13981, CL13990, CL13991, CL1
00191506043131
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.